This invention relates to an improved transfer set for vials and other medical containers which may be attached to a conventional vial, for example, having an elastomeric stopper or other closure for transferring fluid under sterile conditions between the medical container and a second container such as a conventional intravenous (IV) infusion bag. The transfer set of this invention assures sterile delivery of the substance in the container, provides clear indication of tampering and protects the healthcare worker.
It is conventional to store pharmaceutical substances such as drugs in a sealed vial or other container for later use. Such pharmaceuticals may be in a dry or powdered form to increase the shelf life of the substance and reduce inventory space. Such dry or powdered substances are generally stored in a sealed vial and reconstituted in liquid form for administration to a patient by adding diluent or solvent. Alternatively, the substance may in a liquid or even a gaseous form.
A conventional vial for storing such substances generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper or closure which includes a generally tubular portion or an annular rib which is inserted into the neck of the vial and a generally planar rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. The aluminum cap includes a tubular portion which surrounds the rim portion of the stopper and vial, an inwardly projecting annular rim portion which overlies the rim portion of the stopper and a free end portion which is crimped or deformed radially into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and rim portion. The dimensions and tolerances of standard vials and rims are set by the International Standards Organization (ISO).
The radial portion of the aluminum cap which overlies the stopper rim portion may be closed, in which case the aluminum cap is removed by peeling the aluminum cap from the vial. A pre-slit tab located in the midportion is provided which overlies the vial rim, permitting the cap to be torn from the top and peeled from the vial prior to use. This embodiment of an aluminum cap has several disadvantages. First, the tearing the metal cap creates sharp edges which may cut or damage sterile gloves and cut the healthcare person administering the drug, thereby exposing both the healthcare worker and the patient to disease and contamination of the drug. Second, the tearing of the aluminum cap generates metal particles which may also contaminant the drug. The dangers associated with the tearing of an aluminum cap has been solved in part by adding a xe2x80x9cflip-offxe2x80x9d plastic cap. This embodiment, however, does not eliminate the possibility of tearing the sterile gloves of the healthcare worker. Further, aluminum dust is still created which may contaminant the medicament. It should also be noted that metallic dust is also created by forming and affixing the aluminum collar to the vial, particularly during the crimping of the vial and removal of the flip-off plastic cap.
Aluminum collars have also been used to secure fluid transfer sets on vials. Transfer sets may be utilized, for example, to transfer fluid from a syringe to a vial or an IV infusion bag to a vial such as to reconstitute a dry or powdered drug in a vial by adding diluent or solvent. The reconstituted drug may then be withdrawn from the vial into the IV infusion bag or a syringe. There have been attempts to reduce this problem by applying a coating to the aluminum cap or collar. The prior art also includes snap-on cup-shaped plastic caps or collars having a radially inwardly projecting end portion that is snapped over the rim portion of the vial. Snap-on plastic collars, however, do not assure adequate sealing of the vial or full accommodation of the tolerances of standard vials and stoppers as required.
As discussed below, the disclosed embodiment of the fluid transfer set of this invention is particularly, but not exclusively, adapted for transferring fluids between a sealed container, such a vial having an elastomeric stopper, and an IV infusion bag. A conventional IV infusion bag includes one or a plurality of tubular ports which are sealed prior to use. As set forth above, the vial or other medical container is also sealed. The transfer of fluids between a vial and an IV infusion bag for example requires piercing of the seal in the port to the IV infusion bag and communication with the interior of the vial generally provided by piercing the elastomeric stopper. In a typical application, the vial includes a dry or powdered substance and the IV infusion bag includes a liquid solvent or diluent. It is thus necessary to transfer the liquid in the IV infusion bag to the dry or powdered medicament in the vial to reconstitute the drug, then transfer the reconstituted drug to the IV infusion bag.
Various improvements have been made to transfer sets for transferring fluid between medicament vials and IV infusion sets, particularly the MONOVIAL(copyright) prefillable IV infusion system offered by the assignee of the present invention as disclosed, for example, in U.S. Pat. Nos. 5,487,737; 5,533,994; and particularly 5,855,575 assigned to the Assignee of the present invention. These improvements include safeguards against damage and contamination and a shield around the needle cannula used to pierce the tubular port of IV infusion bag which safeguards the healthcare worker. This transfer set system, however, requires a special stopper or closure for the vial. Reference is also made to U.S. Pat. No. 5,250,037 assigned to the assignee of the present invention which discloses an improved syringe having needle isolation features, wherein the needle cannula extends from both ends of the needle holder for transfer of fluids between the syringe and a second container such as an IV infusion bag. The barrel portion includes bayonet grooves and the closure includes projections received in the bayonet grooves, such that rotation of the closure drives the proximate end of the needle cannula through a seal on the syringe. The transfer assembly disclosed in that patent, however, requires a special syringe.
The transfer set assembly of this invention may be utilized with any sealed container including conventional sealed pharmaceutical vials preferably having ports up to 14.5 mm and may be utilized to transfer fluids between the sealed container and any second container, including a conventional IV infusion bag. Further, the transfer set of this invention assures sterile conditions of the transfer set during filling of the container and use of the transfer set and container assembly. Finally, the transfer set of this invention is simple to operate and protects the healthcare worker during use.
As set forth above, the transfer set assembly of this invention may be utilized to transfer fluids between a first container having a sealed open end, such as a conventional vial having an elastomeric stopper, and a second container, such as a conventional IV infusion bag, under sterile conditions. It is important to emphasize, however that the use of the transfer set assembly of this invention is not limited to any particular container, such as the conventional vial or an IV infusion bag as described herein.
The transfer set assembly of this invention includes a collar, a needle cannula and holder assembly, and a closure. The collar includes a proximate tubular end portion which is adapted to be received over the sealed open end of the first container for securement to the container. In the most preferred embodiment of the transfer set assembly of this invention, the collar is formed of a polymer which is sufficiently malleable to permit radial deformation of the free end of the proximate tubular end portion, into the reduced diameter neck portion of a vial, for example, to secure the collar to the sealed open end of the first container, yet sufficiently rigid to maintain its shape following deformation and sufficiently resistant to creep to maintain the seal between the transfer set and the first container. The most preferred polymer is a composite polymer including a relatively soft malleable polymer and a relatively rigid polymer. The collar further includes an intermediate portion having an axial opening, which receives the needle cannula as described below, and a distal tubular portion. For ease of description and understanding, the term xe2x80x9cdistalxe2x80x9d is used herein to refer to the portions of a component of the transfer set which are more distant or distal from the sealed container to which the transfer set is attached. The term xe2x80x9cproximatexe2x80x9d is used for the portion of a component which are closer or proximate to the container.
The needle cannula holder includes a proximate end portion which is telescopically received in the distal tubular portion of the collar and a tubular distal end portion. The tubular distal end portion of the holder includes an angled camming surface, or surfaces. The needle cannula is supported and secured in the holder and includes a free proximate end portion which projects axially beyond the proximate end portion of the holder for piercing the sealed open end of the first container as described below.
The closure or cap includes a tubular body portion having an open end which is telescopically received over the needle cannula and holder assembly and the distal tubular portion of the collar, a closed distal end portion and an angled camming surface or surfaces which engages the angled camming surfaces on the holder. Thus, rotation of the closure relative to the collar and the holder drives the needle cannula and holder assembly axially, causing the projecting end of the needle cannula to pierce the open end of the container and provide communication between the first container and a second container.
In the most preferred embodiment, the mating camming surfaces are helical and the closure and holder include two mating camming surfaces providing sufficient force to assure piercing of the sealed open end of the first container and balancing the driving force. Further, the distal tubular portion of the collar and the needle cannula holder include an interlocking axial rib and groove which permits telescopic movement of the needle cannula and holder assembly within the distal tubular portion of the collar while preventing rotational movement of the holder relative to the collar.
As described above, the mating camming surfaces of the closure and the needle cannula holder assure piercing of the sealed open end of the first container by the needle cannula. The closure may then be removed to establish communication between the first container and a second container. However, it would also be desirable to drive the closure from the needle cannula and holder assembly and the collar and provide evidence that the seal has been fully pierced. In the preferred embodiment, the open proximate end portion of the closure is closely telescopically received over the distal tubular portion of the collar to prevent contamination of the transfer set assembly and assure maintenance of sterile conditions. It is also desirable to securely retain the closure on the transfer set prior to use to assure the sterile condition of the transfer set and prior to full piercing of the sealed open end of the first container when the transfer set is ready for use.
These goals are accomplished in the disclosed embodiment of the transfer set of this invention by providing a laterally extending slot or groove adjacent the free open end of the tubular body portion of the closure and a projection on the distal tubular portion of the collar which is received in the slot. The inside surface of the tubular body portion of the closure further includes an angled camming surface contiguous with the slot which receives the projection on the collar when piercing of the sealed open end of the container by the needle cannula is complete. Thus, the closure is securely retained on the collar during the initial rotation of the collar to pierce the sealed open end of the container. In the disclosed preferred embodiment, two projections are provided on opposed sides of the tubular distal portion at the collar which are received in lateral slots on opposed sides of the closure. Continued rotation of the closure relative to the collar following piercing of the seal on the first container then disposes the projection on the collar into the contiguous angled camming surface, driving the closure from the collar. As will be understood, however, this arrangement can be reversed, wherein the projection is located on the internal surface of the body portion of the closure and the slot and camming surface is provided on the external surface of the distal tubular portion of the collar.
The transfer set assembly of this invention is thus simple to use and provides a substantially foolproof operation. When the transfer set is ready for use, the healthcare worker simply rotates the closure relative to the collar which drives the needle cannula and holder assembly axially to pierce the sealed opening of the first container. Continued rotation of the collar in the same direction then drives the closure from the collar, thereby releasing the closure and providing a clear indication to the healthcare worker that the closure may be removed and the transfer set is ready for use. Various tamper indicators may also be included with the transfer set assembly of this invention. First, the closure may be releasably affixed to the proximate tubular end portion of the collar by a frangible connector, such that when the closure is turned during use, the frangible connector is broken providing clear indication that the closure has been removed. Second, a frangible connector may be applied across the slot which receives the projection on the collar, indicating that the closure has been turned and preventing inadvertent rotation of the closure. The frangible connectors may take various forms including tape and an integral web which provides clear evidence of tampering.
The improved transfer set assembly of this invention thus achieves the goals of assuring the sterility of the transfer set assembly prior to and during use, is simple and positive in operation and protects the healthcare worker prior to and during use. In the disclosed embodiment of the transfer set assembly of this invention which is particularly, but not exclusively, adapted for transferring fluids between a first container having a sealed open end and a IV infusion bag, the needle cannula extends through the intermediate portion of the holder toward the closed distal end of the closure and the tubular distal portion of the holder extends beyond the free upper end of the needle cannula to serve as a shield for the healthcare worker. In the most preferred embodiment, the tubular distal portion includes axial slots which allows the healthcare worker to clearly see the exposed needle cannula for attachment to the port of the infusion bag and guides the tubular port. These and other advantages and meritorious features of the improved transfer set assembly of this invention will be more fully understood from the following description of the preferred embodiments, the claims and the drawings, a brief description of which follows.